21 CFR 872.3330
§ 872.3330 Preformed crown.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.3330, § 872.3330 Preformed crown, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90078
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Full text
(a) Identification. A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.